Clearance Summary
PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION received FDA 510(k) clearance under submission number K911581, sponsored by Johnson & Johnson Interventional Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1991-06-04.
- Submission: K911581
- Applicant / Sponsor: Johnson & Johnson Interventional Systems
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5010
- Decision date: 1991-06-04
Classification & Regulation
This clearance is catalogued under FDA product code FGE and 21 CFR 876.5010, within the Gastroenterology, Urology review panel as a Class II device.